Eculizumab is a humanized monoclonal antibody that specifically binds to human complement component 5 (C5). Eculizumab has been approved by the FDA for treating paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Eculizumab is typically produced using a large scale (10,000-L) fed batch mammalian cell culture.
Small-scale models of production cell cultures provide a means for testing culture media or media components and/or mammalian cell lines prior to their use in a large scale production cell culture. Small-scale models of productions cell cultures also provide a means for testing culture media or media components and/or mammalian cell lines for contamination prior to their use in large scale production cultures. There is a need for a small scale model of the eculizumab production process.